Rosuvastatin Calcium

Product NDC
50090-7413
11-digit product format
500907413
Labeler code
50090
Product ID
50090-7413_009f1a13-65df-4c69-867f-949d65f20d75
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA079170
Marketing category
ANDA
Marketing start
2016-07-19
Substance
ROSUVASTATIN CALCIUM
Active strength
40 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
83MVU38M7QROSUVASTATIN CALCIUM147098-20-2ROSUVASTATIN CALCIUM

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7413-05009074130030 TABLET, FILM COATED in 1 BOTTLE (50090-7413-0) 2024-10-28NoNoHistorical
50090-7413-15009074130190 TABLET, FILM COATED in 1 BOTTLE (50090-7413-1) 2024-10-28NoNoHistorical
50090-7413-250090741302100 TABLET, FILM COATED in 1 BOTTLE (50090-7413-2) 2024-10-28NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Rosuvastatin CalciumA-S Medication Solutions2024-10-28Human Prescription Drug Label4